Peripheral T-cell Lymphoma
Conditions
Keywords
CD30-positive, CD30-negative, Seattle Genetics
Brief summary
This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.
Interventions
DRUGbrentuximab vedotin
1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
DRUGcyclophosphamide
750 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
DRUGdoxorubicin
50 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
DRUGprednisone
100 mg daily administered orally on Days 1-5 of each cycle
Sponsors
Seagen, a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification * The following non-sALCL PTCL subtypes are eligible: * PTCL - not otherwise specified (PTCL-NOS) * Angioimmunoblastic T-cell lymphoma (AITL) * Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1) * Enteropathy-associated T-cell lymphoma (EATL) * Hepatosplenic T-cell lymphoma * Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL) * Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract * Follicular T-cell lymphoma * Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype * CD30 expression \<10% by local assessment in tumor containing lymph node or other extranodal soft tissue biopsy * Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist * An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion criteria
* Current diagnosis of any of the following: * sALCL * Primary cutaneous T-cell lymphoproliferative disorders and lymphomas * Mycosis fungoides (MF), including transformed MF * History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. * History of progressive multifocal leukoencephalopathy (PML). * Cerebral/meningeal disease related to the underlying malignancy. * Prior treatment with brentuximab vedotin or doxorubicin. * Baseline peripheral neuropathy Grade 2 or higher (per the NCI CTCAE, Version 4.03) or subjects with the demyelinating form of Charcot-Marie-Tooth syndrome. * Left ventricular ejection fraction less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months, or previous treatment with complete cumulative dose of \>300 mg/m2 of doxorubicin. * Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment | At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months | ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment \[EOT\]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment | At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months | CR rate was defined as the percentage of participants with CR following the completion of study treatment (at EOT). CR as per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. |
| Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment | From the first dose of study treatment to first documentation of objective tumor progression or death due to any cause or censoring, whichever came first (approximately 61.7 months) | PFS was defined as the time from start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever came first. Kaplan-Meier method was used for analysis. PFS data was censored on the date of the last radiological assessment of measured lesions documenting absence of PD for participants without objective tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment or stem cell transplant (included donor lymphocyte infusion) or were removed from study prior to documentation of objective tumor progression. Participants who lacked an evaluation of tumor response after their first dose had their event time censored at 1 day. |
| Overall Survival (OS) by Central CD30 Assessment | From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months) | OS was defined as the time from first dose to death due to any cause. Participant not known to have died by the end of study follow-up, observation of OS was censored on the date the participants were last known to be alive (i.e., date of last contact). Participants who lacked data beyond the day of first dose had their survival time censored on the date of first dose (i.e., OS duration of 1 day). Kaplan-Meier method was used for analysis. |
| Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment | From the first documented CR or PR until the first documentation of tumor progression, death or censoring date, whichever came first (up to 61.7 months) | DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (per Cheson 2007) or death, whichever came first. Participants without progression or death were censored. DOR was only calculated for the subset of participants achieving a CR or PR. CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Kaplan-Meier method was used for analysis. |
| ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment | At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months | ORR was defined as the percentage of participants with CR or PR following the completion of study treatment (at EOT) according to the modified Lugano criteria (Cheson 2014). Complete response was defined as complete disappearance of radiologic evidence of disease and PR was defined as at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months) | An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An adverse event was classified as a serious adverse event (SAE) if it met one of the following criteria: fatal, life threatening, hospitalization, disabling/incapacitating, congenital anomaly or birth defect or any medically significant event. TEAEs were events if they were newly occurring or worsen following study treatment. TESAE is any SAE that met treatment emergent definition. Treatment related AEs were which had evidence to suggest a causal relationship between the drugs and the adverse event, such as: an event that was uncommon and known to be strongly associated with drug exposure, an event that was not commonly associated with drug exposure but was otherwise uncommon in the population exposed to the drug. AEs included both SAEs and all non-SAEs. |
| Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months) | Any Abnormal laboratory tests(Decreased values of hemoglobin,leukocytes,lymphocytes,neutrophils, platelets, calcium corrected for albumin,glomerular filtration rate estimated, glucose, phosphate, potassium,albumin,sodium and increased values of calcium corrected for albumin,creatinine, potassium, glucose, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total Bilirubin, urate) that worsen from baseline were considered clinically significant by investigator.Abnormal test were recorded as AE if associated with accompanying symptoms,required additional diagnostic testing or medical/surgical intervention,study dosing change,study discontinuation,significant additional concomitant drug treatment,other therapy.As perNCI CTCAE grade(G)1:mild(asymptomatic or mild symptoms,clinical,diagnostic observations,no intervention),G2:moderate(minimal, local,noninvasive intervention),G3:severe,medically significant,G4:life-threatening,urgent intervention,G5:death related to AE |
Countries
France, Italy, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Participant flow
Recruitment details
Participants who had newly diagnosed non-systemic anaplastic large cell lymphoma (sALCL) peripheral T-cell lymphoma (PTCL) with \< 10% CD30 expression, were enrolled to receive A+CHP treatment (brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone). Enrollment was based on CD30 expression per local laboratory assessment. Analysis of efficacy outcome measures was based on CD30 expression per central laboratory assessment.
Pre-assignment details
Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.
Participants by arm
| Arm | Count |
|---|---|
| CD30 <1% [Local Laboratory Assessment] Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. | 34 |
| CD30 1% to <10% [Local Laboratory Assessment] Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle. | 48 |
| Total | 82 |
Baseline characteristics
| Characteristic | CD30 1% to <10% [Local Laboratory Assessment] | Total | CD30 <1% [Local Laboratory Assessment] |
|---|---|---|---|
| Age, Continuous | 61.0 Years STANDARD_DEVIATION 11 | 60.7 Years STANDARD_DEVIATION 11.1 | 60.2 Years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 19 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 56 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 37 Participants | 63 Participants | 26 Participants |
| Sex: Female, Male Female | 26 Participants | 36 Participants | 10 Participants |
| Sex: Female, Male Male | 22 Participants | 46 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 34 | 13 / 48 |
| other Total, other adverse events | 31 / 34 | 43 / 48 |
| serious Total, serious adverse events | 15 / 34 | 16 / 48 |
Outcome results
Primary
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment \[EOT\]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
Time frame: At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
Population: Full analysis set (FAS) included all participants who received any amount of brentuximab vedotin or any component of cyclophosphamide, doxorubicin, and prednisone (CHP). Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD30 <1% [Central Laboratory Assessment] | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment | 61 Percentage of participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment | 81 Percentage of participants |
Secondary
Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment
CR rate was defined as the percentage of participants with CR following the completion of study treatment (at EOT). CR as per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
Time frame: At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
Population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD30 <1% [Central Laboratory Assessment] | Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment | 52 Percentage of participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment | 71 Percentage of participants |
Secondary
Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment
DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (per Cheson 2007) or death, whichever came first. Participants without progression or death were censored. DOR was only calculated for the subset of participants achieving a CR or PR. CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Kaplan-Meier method was used for analysis.
Time frame: From the first documented CR or PR until the first documentation of tumor progression, death or censoring date, whichever came first (up to 61.7 months)
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment
An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An adverse event was classified as a serious adverse event (SAE) if it met one of the following criteria: fatal, life threatening, hospitalization, disabling/incapacitating, congenital anomaly or birth defect or any medically significant event. TEAEs were events if they were newly occurring or worsen following study treatment. TESAE is any SAE that met treatment emergent definition. Treatment related AEs were which had evidence to suggest a causal relationship between the drugs and the adverse event, such as: an event that was uncommon and known to be strongly associated with drug exposure, an event that was not commonly associated with drug exposure but was otherwise uncommon in the population exposed to the drug. AEs included both SAEs and all non-SAEs.
Time frame: From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)
Population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | TEAEs | 32 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | TESAEs | 15 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | Treatment related TEAEs | 25 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | TEAEs | 46 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | TESAEs | 16 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment | Treatment related TEAEs | 40 Participants |
Secondary
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment
Any Abnormal laboratory tests(Decreased values of hemoglobin,leukocytes,lymphocytes,neutrophils, platelets, calcium corrected for albumin,glomerular filtration rate estimated, glucose, phosphate, potassium,albumin,sodium and increased values of calcium corrected for albumin,creatinine, potassium, glucose, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total Bilirubin, urate) that worsen from baseline were considered clinically significant by investigator.Abnormal test were recorded as AE if associated with accompanying symptoms,required additional diagnostic testing or medical/surgical intervention,study dosing change,study discontinuation,significant additional concomitant drug treatment,other therapy.As perNCI CTCAE grade(G)1:mild(asymptomatic or mild symptoms,clinical,diagnostic observations,no intervention),G2:moderate(minimal, local,noninvasive intervention),G3:severe,medically significant,G4:life-threatening,urgent intervention,G5:death related to AE
Time frame: From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)
Population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Here, Overall Number of Participants Analyzed were participants evaluable for this outcome measure however all participants reported under Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, Number Analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Urate increased: Grade 4 | 2 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Aspartate Aminotransferase increased: Grade 3 | 0 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Calcium Corrected for Albumin decreased: Grade 1+2 | 2 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium increased: Grade 1+2 | 2 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium increased: Grade 3 | 1 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Sodium decreased: Grade 1+2 | 8 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Sodium decreased: Grade 3 | 1 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Sodium increased: Grade 1+2 | 0 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Total Bilirubin increased: Grade 1+2 | 1 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Urate increased: Grade 3 | 4 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Aspartate Aminotransferase increased: Grade 1+2 | 8 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Hemoglobin decreased: Grade 1+2 | 19 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Hemoglobin decreased: Grade 3 | 3 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Leukocytes decreased: Grade 1+2 | 13 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Leukocytes decreased: Grade 3 | 4 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Leukocytes decreased: Grade 4 | 0 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Lymphocytes decreased: Grade 1+2 | 10 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Lymphocytes decreased: Grade 3 | 15 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Lymphocytes decreased: Grade 4 | 1 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Neutrophils decreased: Grade 1+2 | 3 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Neutrophils decreased: Grade 3 | 4 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Neutrophils decreased: Grade 4 | 1 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Platelets decreased: Grade 1+2 | 6 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Platelets decreased: Grade 4 | 0 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Calcium Corrected for Albumin increased: Grade 1+2 | 3 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Creatinine increased: Grade 1+2 | 19 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glomerular Filtration Rate, Estimated decreased: Grade 1+2 | 2 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glucose decreased: Grade 1+2 | 1 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glucose increased: Grade 1+2 | 15 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glucose increased: Grade 3 | 3 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glucose increased: Grade 4 | 0 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Phosphate decreased: Grade 1+2 | 1 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Phosphate decreased: Grade 3 | 0 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium decreased: Grade 1+2 | 2 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium decreased: Grade 3 | 1 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium decreased: Grade 4 | 0 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Alanine Aminotransferase increased: Grade 1+2 | 6 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Albumin decreased: Grade 1+2 | 3 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Alkaline Phosphatase increased: Grade 1+2 | 2 Participants |
| CD30 <1% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Alkaline Phosphatase increased: Grade 3 | 2 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Albumin decreased: Grade 1+2 | 8 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Aspartate Aminotransferase increased: Grade 1+2 | 15 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Neutrophils decreased: Grade 3 | 3 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Aspartate Aminotransferase increased: Grade 3 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glucose increased: Grade 4 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Calcium Corrected for Albumin decreased: Grade 1+2 | 2 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Neutrophils decreased: Grade 4 | 3 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium increased: Grade 1+2 | 4 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium decreased: Grade 4 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium increased: Grade 3 | 0 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Platelets decreased: Grade 1+2 | 10 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Sodium decreased: Grade 1+2 | 6 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Phosphate decreased: Grade 1+2 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Sodium decreased: Grade 3 | 3 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Platelets decreased: Grade 4 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Sodium increased: Grade 1+2 | 2 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Alkaline Phosphatase increased: Grade 3 | 0 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Total Bilirubin increased: Grade 1+2 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Calcium Corrected for Albumin increased: Grade 1+2 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Urate increased: Grade 3 | 6 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Phosphate decreased: Grade 3 | 4 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Urate increased: Grade 4 | 0 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Creatinine increased: Grade 1+2 | 30 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Hemoglobin decreased: Grade 1+2 | 34 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Alanine Aminotransferase increased: Grade 1+2 | 17 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Hemoglobin decreased: Grade 3 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glomerular Filtration Rate, Estimated decreased: Grade 1+2 | 4 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Leukocytes decreased: Grade 1+2 | 23 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium decreased: Grade 1+2 | 5 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Leukocytes decreased: Grade 3 | 5 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glucose decreased: Grade 1+2 | 5 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Leukocytes decreased: Grade 4 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Alkaline Phosphatase increased: Grade 1+2 | 11 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Lymphocytes decreased: Grade 1+2 | 15 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glucose increased: Grade 1+2 | 21 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Lymphocytes decreased: Grade 3 | 21 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Potassium decreased: Grade 3 | 1 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Lymphocytes decreased: Grade 4 | 4 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Glucose increased: Grade 3 | 0 Participants |
| CD30 1% to <10% [Central Laboratory Assessment] | Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment | Neutrophils decreased: Grade 1+2 | 12 Participants |
Secondary
ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment
ORR was defined as the percentage of participants with CR or PR following the completion of study treatment (at EOT) according to the modified Lugano criteria (Cheson 2014). Complete response was defined as complete disappearance of radiologic evidence of disease and PR was defined as at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses.
Time frame: At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
Population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD30 <1% [Central Laboratory Assessment] | ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment | 57 Percentage of participants |
| CD30 1% to <10% [Central Laboratory Assessment] | ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment | 77 Percentage of participants |
Secondary
Overall Survival (OS) by Central CD30 Assessment
OS was defined as the time from first dose to death due to any cause. Participant not known to have died by the end of study follow-up, observation of OS was censored on the date the participants were last known to be alive (i.e., date of last contact). Participants who lacked data beyond the day of first dose had their survival time censored on the date of first dose (i.e., OS duration of 1 day). Kaplan-Meier method was used for analysis.
Time frame: From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months)
Secondary
Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment
PFS was defined as the time from start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever came first. Kaplan-Meier method was used for analysis. PFS data was censored on the date of the last radiological assessment of measured lesions documenting absence of PD for participants without objective tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment or stem cell transplant (included donor lymphocyte infusion) or were removed from study prior to documentation of objective tumor progression. Participants who lacked an evaluation of tumor response after their first dose had their event time censored at 1 day.
Time frame: From the first dose of study treatment to first documentation of objective tumor progression or death due to any cause or censoring, whichever came first (approximately 61.7 months)